Prediction of Postoperative Pain Using Venous Cannulation Pain and Preoperative Anxiety Scores

March 4, 2026 updated by: Arsen Gungor Ay, Fatih Sultan Mehmet Training and Research Hospital

Association of Venous Cannulation Pain and Preoperative Anxiety (APAIS) With Postoperative Pain Following Elective Laparoscopic Cholecystectomy: A Prospective Observational Study

Postoperative pain remains a significant clinical problem affecting recovery, mobilization, and patient satisfaction after surgery. Considerable interindividual variability exists in postoperative pain intensity even among patients undergoing the same surgical procedure. This variability may be influenced not only by the extent of surgical trauma but also by individual pain sensitivity and psychological factors such as preoperative anxiety.

The aim of this prospective observational study is to evaluate whether pain intensity reported during routine venous cannulation and preoperative anxiety levels assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) can predict early postoperative pain severity in patients undergoing elective laparoscopic cholecystectomy under general anesthesia. Venous cannulation pain will be assessed using a 0-10 visual analog scale (VAS), and anxiety levels will be measured preoperatively using APAIS. Postoperative pain will be evaluated at predefined time points within the first 12 hours after surgery using VAS scores and analgesic consumption. Identifying simple and easily obtainable preoperative predictors may allow individualized postoperative analgesic strategies for patients at higher risk of severe postoperative pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain is a common and clinically relevant problem that negatively affects recovery, early mobilization, patient satisfaction, and overall surgical outcomes. Despite standardized anesthetic and analgesic protocols, significant interindividual variability exists in postoperative pain intensity among patients undergoing the same surgical procedure. This variability may be influenced not only by surgical factors but also by individual pain sensitivity and psychological characteristics, particularly preoperative anxiety.

Pain experienced during routine preoperative procedures such as venous cannulation may reflect individual pain sensitivity and central pain processing mechanisms. Similarly, elevated preoperative anxiety levels have been associated with increased postoperative pain intensity and higher analgesic requirements. The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a validated instrument widely used to quantify preoperative anxiety.

This prospective observational study aims to investigate the predictive value of pain reported during venous cannulation and preoperative anxiety levels assessed by APAIS on early postoperative pain severity in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.

After obtaining ethics committee approval and written informed consent, adult patients (≥18 years) classified as ASA I-III and scheduled for elective laparoscopic cholecystectomy under general anesthesia will be enrolled. Patients undergoing emergency surgery, conversion to open surgery, those with cognitive impairment, chronic pain lasting more than three months, multiple venous cannulation attempts (≥3), or surgical duration exceeding two hours will be excluded.

Preoperative anxiety will be assessed using APAIS prior to transfer to the operating room. Venous cannulation will be performed routinely with a 20G intravenous catheter on the dorsum of the hand by an experienced practitioner. Pain intensity during cannulation will be assessed using a 0-10 visual analog scale (VAS).

All patients will receive standardized general anesthesia and postoperative analgesia according to institutional protocols. Postoperative pain intensity will be evaluated using VAS at predefined time points: upon arrival in the post-anesthesia care unit, at 30 minutes, 2 hours, 6 hours, and 12 hours postoperatively. Rescue analgesia and total analgesic consumption during the first 12 hours will be recorded.

Statistical analysis will evaluate correlations between venous cannulation pain, APAIS scores, and postoperative VAS scores. Multivariable regression analysis will be performed to identify independent predictors of postoperative pain intensity.

By identifying simple and easily obtainable preoperative indicators of postoperative pain risk, this study aims to contribute to individualized analgesic strategies and improved perioperative pain management.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population includes adult patients undergoing elective laparoscopic cholecystectomy under standardized general anesthesia

Description

Inclusion Criteria:

  • Age ≥18 years
  • ASA physical status I-III
  • Scheduled for elective laparoscopic cholecystectomy under general anesthesia
  • Ability to understand and use the Visual Analog Scale (VAS)
  • Ability to complete the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
  • Provision of written informed consent

Exclusion Criteria:

  • Emergency surgery
  • Conversion from laparoscopic to open surgery
  • Cognitive impairment or inability to communicate effectively
  • Chronic pain lasting longer than 3 months
  • More than three venous cannulation attempts
  • Surgical duration exceeding 2 hours
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients Undergoing Elective Laparoscopic Cholecystectomy
Adult patients (≥18 years) classified as ASA physical status I-III and scheduled for elective laparoscopic cholecystectomy under general anesthesia will be enrolled. Patients undergoing emergency surgery, conversion to open surgery, those with cognitive impairment, chronic pain lasting more than three months, multiple venous cannulation attempts (≥3), or surgical duration exceeding two hours will be excluded. All participants will undergo standardized anesthesia and postoperative analgesia according to institutional protocols.
Other: APAIS Assessment
Preoperative anxiety is evaluated using the Amsterdam Preoperative Anxiety and Information Scale (APAIS).Pain during routine venous cannulation is assessed using a 0-10 visual analog scale (VAS).
Other Names:
  • Venous Cannulation Pain Assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Postoperative Pain Intensity
Time Frame: Within the first 12 hours after surgery (upon arrival in the post-anesthesia care unit, at 30 minutes, 2 hours, 6 hours, and 12 hours postoperatively)
Postoperative pain intensity assessed using a 0-10 visual analog scale (VAS).
Within the first 12 hours after surgery (upon arrival in the post-anesthesia care unit, at 30 minutes, 2 hours, 6 hours, and 12 hours postoperatively)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Analgesic Consumption
Time Frame: First 12 hours after surgery
Total amount of analgesic medications administered during the first 12 postoperative hours, including rescue analgesics.
First 12 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 4, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 4, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVLINEVAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The final decision regarding individual participant data (IPD) sharing has not yet been determined. Data sharing policies will be established following completion of the study and publication of the primary results, in accordance with institutional regulations and ethical considerations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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